FDA to provide guidances on how to appeal rejected applications -- CDER'S Woodcock.
This article was originally published in The Tan Sheet
Executive Summary
FDA TO INCLUDE APPEALS GUIDANCES WITH REJECTED DRUG APPLICATIONS, Center for Drug Evaluation & Research Director Janet Wood-cock, MD, reported at a Nov. 9 Food & Drug Law Institute/FDA-sponsored video conference. Responding to industry complaints that companies do not "know how to appeal" agency decisions, CDER will append to rejected NDAs and INDs "some general information on how to appeal and what your rights are," Woodcock explained.